| Primary Device ID | 00853592008035 |
| NIH Device Record Key | fa92ae9f-d2de-408e-8122-ce7c57c1fe95 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Ansh Labs Inhibin B ELISA (CE) |
| Version Model Number | AL-107-i |
| Catalog Number | AL-107-i |
| Company DUNS | 057752914 |
| Company Name | Ansh Labs, LLC |
| Device Count | 1 |
| DM Exempt | true |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | true |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | true |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
| Phone | (281) 404-0260 |
| TechSupport@AnshLabs.com | |
| Phone | (281) 404-0260 |
| TechSupport@AnshLabs.com | |
| Phone | (281) 404-0260 |
| TechSupport@AnshLabs.com | |
| Phone | (281) 404-0260 |
| TechSupport@AnshLabs.com | |
| Phone | (281) 404-0260 |
| TechSupport@AnshLabs.com | |
| Phone | (281) 404-0260 |
| TechSupport@AnshLabs.com | |
| Phone | (281) 404-0260 |
| TechSupport@AnshLabs.com | |
| Phone | (281) 404-0260 |
| TechSupport@AnshLabs.com | |
| Phone | (281) 404-0260 |
| TechSupport@AnshLabs.com | |
| Phone | (281) 404-0260 |
| TechSupport@AnshLabs.com | |
| Phone | (281) 404-0260 |
| TechSupport@AnshLabs.com | |
| Phone | (281) 404-0260 |
| TechSupport@AnshLabs.com | |
| Phone | (281) 404-0260 |
| TechSupport@AnshLabs.com | |
| Phone | (281) 404-0260 |
| TechSupport@AnshLabs.com | |
| Phone | (281) 404-0260 |
| TechSupport@AnshLabs.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00853592008035 [Primary] |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2021-06-10 |
| Device Publish Date | 2021-06-02 |
| 00853592008103 - Ansh Labs AnshCheck AMH Tri-Level Controls | 2021-06-11 Ansh Labs AMH Tri-Level Controls are intended for use as assay quality controls to monitor the precision and reproducibility of |
| 00853592008004 - Ansh Labs Ultrasensitive AMH/MIS ELISA | 2021-06-10 The Ultra-Sensitive Anti-Müllerian hormone/ Müllerian inhibiting substance (US AMH/MIS) enzyme linked immunuosorbent assay (EL |
| 00853592008011 - Ansh Labs picoPAPP-A ELISA (CE) | 2021-06-10 The picoPAPP-A enzyme linked immunosorbent assay (ELISA) kit provides materials for the quantitative measurement of PAPP-A in hu |
| 00853592008028 - Ansh Labs PAPP-A ELISA (CE) | 2021-06-10 The PAPP-A enzyme linked immunosorbent assay (ELISA) kit provides materials for the quantitative measurement of PAPP-A in serum |
| 00853592008035 - Ansh Labs Inhibin B ELISA (CE) | 2021-06-10The Inhibin B enzyme linked immunosorbent assay (ELISA) kit provides materials for the quantitative measurement of Inhibin B in human serum and other biological fluids. This assay is intended for in vitro diagnostic use |
| 00853592008035 - Ansh Labs Inhibin B ELISA (CE) | 2021-06-10 The Inhibin B enzyme linked immunosorbent assay (ELISA) kit provides materials for the quantitative measurement of Inhibin B in |
| 00853592008066 - Ansh Labs Total IGF-I ELISA (CE) | 2021-06-10 The Total IGF-I enzyme linked immunosorbent assay (ELISA) kit provides materials for the quantitative measurement of IGF-I in se |
| 00853592008073 - Ansh Labs Inhibin A ELISA | 2021-06-10 The Inhibin A enzyme linked immunosorbent assay (ELISA) kit provides materials for the quantitative measurement of dimeric inhib |
| 00853592008080 - Ansh Labs picoAMH ELISA | 2021-06-10 The picoAMH ELISA is an enzyme-linked immunosorbent assay (ELISA) for the quantitative measurement of anti-Müllerian hormone (A |